Karuna Therapeutics Inc KRTX has announced topline results from its Phase 3 EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults with schizophrenia.
The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo.
PANSS is a medical scale to measure symptom severity in schizophrenia patients.
KarXT also demonstrated an early and sustained statistically significant reduction of symptoms, starting at Week 2, and maintained such reduction through all time points in the trial.
KarXT also met key secondary endpoints, demonstrating a statistically significant reduction in both positive symptoms (e.g., hallucinations or delusions) and negative symptoms (e.g., difficulty enjoying life or withdrawal from others) of schizophrenia.
KarXT was generally well tolerated. Overall discontinuation rates were similar between KarXT and placebo groups (25% vs. 21%).
The EMERGENT program consists of the completed Phase 2 EMERGENT-1 and Phase 3 EMERGENT-2 trials and three ongoing trials evaluating the acute efficacy and long-term safety of KarXT (EMERGENT-3, EMERGENT-4, and EMERGENT-5).
Topline data from the Phase 3 EMERGENT-3 trial are expected in Q1 of 2023. The company plans to submit a marketing application in mid-2023.
Zai Lab Ltd ZLAB shares are trading 12.8% higher at $51.05 as its announced licensing agreement with Karuna Therapeutics for KarXT in Greater China for psychiatric conditions.
Price Action: KRTX shares are up 52.90% at $214.61a during the premarket session on the last check Monday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.